Health Condition 1: J841- Other interstitial pulmonary diseases with fibrosis
Conditions
Interventions
Intervention1: LYT-100: 550 mg LYT-100 three times a day over a 26-week treatment period (6 months)
825 mg LYT-100 three times a day over a 26-week treatment period (6 months)
Control Intervention1:
Sponsors
PureTech LYT Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written, electronic, or oral informed consent from the patient prior to any study procedures in a manner approved by an IRB or Ethics Committee (EC) 2. Male or female, aged =40 to =80 at the time of informed consent 3. Able to perform and willing to comply with all study procedures and requirements 4. Treatment-naïve patients with physician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines 5. IPF on HRCT, performed within 12 months of Visit 1 as confirmed by central reader 6. The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan as determined by the investigator 7. Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin (Hb) [Visit 1] =30% and 8. FVC =45% of predicted normal 9. Women of childbearing potential (WOCBP) must be non-pregnant and non-lactating, and must be abstinent from heterosexual intercourse throughout the study and for 90 days following last dose of study medication or agree to use one of the acceptable, highly effective methods of double contraception which is defined as male use of a condom AND one form of the following: a. oral, intravaginal, or transdermal combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation b. oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation c. intrauterine device (IUD) 10. Male participants must be surgically sterile ( >30 days since vasectomy with no viable sperm), abstinent, or, if engaged in heterosexual relations, any female partner must be post-menopausal, surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or using an acceptable, highly effective contraceptive method from screening until study completion, including the follow-up period and for no less than 90 days after the last dose of study medication along with the use of male condom 11. Males will not donate sperm for at least 90 days after the last dose of study medication 12. Female partners of male patients and female patients will report pregnancy occurring within 90 days from cessation of study medication
Exclusion criteria
Exclusion criteria: 1. Patients who, in the judgement of the investigator, are unlikely to be able to fulfill study participation requirements 2. Significant clinical worsening (as per Investigator’s discretion) of IPF between Screening and Baseline Visits 3. AST, ALT >1.5 × ULN at Visit 1 4. Bilirubin >1.5 × ULN at Visit 1 5. Creatinine clearance [Note: Laboratory parameters from Visit 1 will be used to satisfy the laboratory threshold values as shown above. Visit 2 laboratory results may be available only after randomization. If the Visit 2 results no longer satisfy the entry criteria, the Investigator will determine whether it is justified that the patient remains on study drug. The justification for this decision needs to be documented.] 6. Patients with underlying chronic liver disease (Child Pugh A, B, or C hepatic impairment) 7. Current or prior treatment with nintedanib or pirfenidone 8. Other investigational therapy received within 1 month prior to randomization (Visit 2) 9. Significant pulmonary arterial hypertension (PAH) defined by any of the following: a. Previous clinical or echocardiographic evidence of significant right heart failure b. History of right heart catheterization showing a cardiac index =2 L/min/m² c. PAH requiring subcutaneous or intravenous therapy with epoprostenol/treprostinil 10. Primary obstructive airway physiology (pre-bronchodilator forced expiratory volume in the first second [FEV1]/FVC 11. Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer 12. Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis 13. In the opinion of the Investigator, other clinically significant pulmonary abnormalities, including prior or current lung cancer (treated within the past 5 years) 14. Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion) 15. Cardiovascular diseases, any of the following: a. Uncontrolled hypertension, under treatment, within 3 months of Visit 1 b. Myocardial infarction within 6 months of Visit 1 c. Unstable cardiac angina within 6 months of Visit 1 16. Prior hospitalization for confirmed COVID-19, acute exacerbation of IPF or any lower respiratory tract infection within 3 months prior to enrollment 17. Known symptoms of dysphagia or known difficulty in swallowing capsules and/or total gastrectomy 18. Use of any of the following drugs within 2 weeks prior to Visit 2/baseline, during the screening period or planned during the duration of the study a. Strong and moderate CYP1A2 inhibitors (i.e., ciprofloxacin, fluvoxamine, verapamil or enoxacin) and St John’s Wort or phenytoin (moderate inducers of CYP1A) b. Drugs associated with substantial risk for prolongation of the QTc interval (including but not limited to moxifloxacin, quinidine, procainamide, amiodarone, sotalol) c. Warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporin A, bosentan, methotrexate, sildenafil (exce
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Assess the relative efficacy of LYT-100 as compared to pirfenidoneTimepoint: End of treatment;Obtain point estimates and measures of variability of efficacy endpoints in order to determine sample size for Phase 3 study.Timepoint: End of treatment | — |
Primary
| Measure | Time frame |
|---|---|
| To obtain clinical data establishing the efficacy, tolerability, safety, and dosing regimen of LYT-100 in patients with IPF in order to determine the dose to carry forward into Phase 3.Timepoint: End of treatment | — |
Countries
Argentina, Chile, Colombia, Georgia, Greece, India, Malaysia, Mexico, Poland, Republic of Korea, Romania, Serbia, Thailand, United States of America
Contacts
Public ContactKanhaiya Choudhary
Novotech India Private Limited
Outcome results
None listed